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The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric water exchange | Experimental | Air will be minimally insufflated to partially open the lumen and any residual fluid will be suctioned when the scope passes through the esophagus. Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further. Air will be opened when the scope enter the prepylorus area where there is usually an air pocket. The scope will enter the duodenal bulb and 2nd portion of duodenum where withdrawal inspection will start. |
|
| Traditional air insufflation | Active Comparator | Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric water exchange | Procedure | Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further. |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort during the procedure | A VAS discomfort score (0, no discomfort; 10, most discomfort) graded by the patient, | 5 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction score | A VAS score (0, not satisfied at all; 10, most satisfied) graded by the patient | 5 minutes after the procedure |
| mucosa cleanliness score | 1, no need for irrigation; 4, need more than 50 ml of water irrigation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Hsi Hsieh, MD | Contact | 886-5-2648000 | 3241 | hsieh.yuhsi@msa.hinet.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Recruiting | Chiayi City | Taiwan | 622 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12145594 | Background | Abraham N, Barkun A, Larocque M, Fallone C, Mayrand S, Baffis V, Cohen A, Daly D, Daoud H, Joseph L. Predicting which patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest Endosc. 2002 Aug;56(2):180-9. doi: 10.1016/s0016-5107(02)70175-2. | |
| 17285514 | Background | Meining A, Semmler V, Kassem AM, Sander R, Frankenberger U, Burzin M, Reichenberger J, Bajbouj M, Prinz C, Schmid RM. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy. 2007 Apr;39(4):345-9. doi: 10.1055/s-2006-945195. Epub 2007 Feb 7. |
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|
| traditional air insufflation | Procedure | Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase. |
|
| 1 minutes after the procedure |
| technique adequacy score | 1, excellent; 6, very poor | 1 minutes after the procedure |